Philips Recalls Ventilators And Sleep Apnea Devices Due To Possible Health Risks

The Dutch medical equipment firm Koninklijke Philips NV RYLPF has recalled several of its sleep apnea and respiratory care devices due to potential health risks.

What Happened: The company stated that its Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices are being recalled because of the polyester-based polyurethane (PE-PUR) sound abatement foam component used in the devices within the DreamStation product line.

"The risks include that the PE-PUR foam may degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals," the company said in a press statement. "The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation."

Philips added that although the complaint rate on this issue was 0.03% during 2020, it nonetheless "determined based on testing that there are possible risks to users related to this type of foam."

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What Happens Next: Philips warned customers who continue to use the recalled products could run into a gamut of health risks from headaches and nausea to possible toxic and carcinogenic effects.

The company said it is working to repair and/or replace the impacted products and added that it anticipated "the expected revenue headwinds in the Sleep & Respiratory Care business in 2021 will be compensated by the strength of the company's other businesses," thus having no effect on full-year comparable sales growth and its adjusted EBITA margin guidance put forth in its most recent earnings report.

(Photo courtesy of Philips.)